Pelvic floor exercise device

ABSTRACT

An improved apparatus is disclosed for use in diagnosing and treating pelvic floor musculature disorders. The device includes a handle ( 18 ) and head ( 10 ) mounted on opposite ends of a shaft ( 12 ), with a barrier ( 14 ) mounted on the shaft ( 12 ) between the handle ( 18 ) and head ( 10 ), and an indicator ( 16 ) mounted on the shaft ( 12 ) between the barrier ( 14 ) and handle ( 18 ). The other apparatus consists of the head ( 10 ) which is detachable from the shaft ( 12 ) and attached to a pin ( 20 ). The apparatus provide magnetic resistance to pelvic floor musculature contraction to ( 1 ) measure and track the progress of pelvic floor musculature strength, and ( 2 ) exercise pelvic floor musculature to improve strength at a private, patient-determined frequency.

FIELD OF THE INVENTION

This invention relates generally to pelvic floor exercises, and morespecifically to devices and methods that can quantify pelvic floordiagnostic findings and monitor and improve pelvic floor strength.

BACKGROUND OF THE INVENTION

Disorders of pelvic support are a significant health care concern,resulting in the loss of billions of dollars annually. Associated withthe rigors of childbirth, trauma, and the aging process, these disordersnot only result in financial loss, but have a profound emotionalcomponent often altering one's self image as well. The resultant loss infunction and selfesteem associated with such disorders is oftenextremely debilitating, leading to prolapse, discomfort, and bothurinary and sexual dysfunction.

To combat these disorders, a variety of therapeutic approaches have beenentertained. Both non-surgical and surgical techniques have beenutilized with varying degrees of success. While surgical managementcertainly has its role, it is not without risk and expense. Medicalmanagement likewise must be carefully individualized, requiring thoroughsurveillance by the prescribing physician.

With this in mind, non-operative therapies to enhance the support ofpelvic tissues are highly desirable. Traditionally, supportive devicessuch as the pessary or specialized pelvic floor exercises, commonlyreferred to as Kegel exercises, have been the mainstay of therapy. Whilepessaries provide artificial support to pelvic floor musculature, Kegelexercises help strengthen such tissues. Patients are trained to utilizeisometric contractions of the pubococcygeus and levator ani muscles tostrengthen the pelvic floor musculature and thus improve function.Utilization of such exercises requires training and motivation, andvariations of such methodology have been successfully utilized andproven with respect to the ability to overcome stress incontinence.

Several investigators have confirmed the benefits of such non-operativetherapies, both subjectively and objectively. Two studies by Henalla, etal, published in the British Journal of Obstetric and Gynecology in 1988and 1989, demonstrated improvement in two-thirds of patients utilizingsuch closely monitored therapy. The later study showed such exercises tobe even more beneficial than both electrical stimulation of the pelvicfloor and estrogen supplementation. Studies such as that of Tchou, etal, published in the 1988 Journal of Physical Therapy confirmed suchoutcomes utilizing urodynamic evaluations, both prior to and afterpelvic floor exercise therapy. In a variation of this theme, Peattie, etal, published in the British Journal of Obstetric and Gynecology in1988, utilized weighted vaginal cones to provide resistance with whichpelvic muscle contraction could be taught, musculature strengthened, andfunction restored.

Critical to the success of such therapy is an understanding of how bestto perform these exercises correctly, considering that when propertechnique is not utilized, the potential for a worsening of functionalso exists. In one study by Bump, et al, published in the AmericanJournal of Obstetric and Gynecology in 1991, less than half of thosegiven either verbal or written instructions were able to illicit anideal Kegel effort as demonstrated by an increase in the force ofurethral closure.

With these principles and concepts in mind, it is clear thatnon-operative means are proven to be successful in improving thefunction of the pelvic floor. Such techniques may be learned and, assuch, the ability to perform them properly is critical to achieving theoutcome desired. It is these aforementioned concepts which have spawneddesire to improve upon the non-operative techniques that havetraditionally been utilized to improve pelvic floor function and furtheralleviate the need for both medical and surgical therapies.

The prior art demonstrates electronic and pneumatic pelvic floorexercise devices, e.g., Sawchuck U.S. Pat. No. 5,733,230 and Sample U.S.Pat. No. 5,674,238, spring-biased exercise devices, e.g., Wallick U.S.Pat. No. 5,865,715, heated and vibrating mechanism exercise devices,e.g., Benderev U.S. Pat. No. 5,782,745, and exercise devices utilizedexternal to the body, e.g., Harris U.S. Pat. No. 5,531,226. However, theprior art poses the threat of further injury to the patient attributedto malfunction of the electronic, thermal, vibrating or pneumatic.Additionally, the complexity of the prior art diminishes reliability, inthat numerous moving parts introduce a higher likelihood formalfunction. Finally, the prior art requires multiple apparatus for theperforming both the diagnosis and treatment of pelvic floor injuries.

In order for pelvic floor disorders to be properly and efficientlydiagnosed, it is highly desirable to provide a non-operative method forboth physician and patient diagnosis, as well as a hygienic and reliablediagnostic tool that is easy to use in private, as an alternative totraditional procedures which can be inaccurate, cumbersome andembarrassing. In order for pelvic floor disorders to be properly andefficiently treated, it is highly desirable to provide a method anddevice allowing patients to perform exercise treatment in private, withselfgoverned frequency, in a simple and hygienic manner, and in anyenvironment.

The disadvantage of the prior art are overcome by the present invention,and an improved pelvic floor exercise device and methods for pelvicfloor musculature dysfunction diagnosis and treatment is hereafterdisclosed.

SUMMARY OF THE INVENTION

The present invention provides a device for diagnosing and treatingpelvic floor dysfunction which, in a preferred embodiment, combines boththe traditional approach of Kegel exercises and an innovation utilizingattractive magnets. This technique allows for several advantages overthe existing technology, in that magnets may be calibrated so as toallow the patient to more properly learn the techniques associated withsuccessful treatment. Further, the patient may follow personal progress,objectively demonstrating improvements in the strength of one's pelvicfloor musculature. This invention offers advantages over the prior artin that performing exercise with the device is not postural based, sincethe magnets may be calibrated so that exercises may be performed in areproducible and progressive manner regardless of body habitus andpositioning. This invention also offers patient safety and theanti-microbial benefits of magnet associated therapies, benefits notoffered by prior art.

The magnetic attraction between a magnetic head and barrier may providea biasing feature against which the contracting pelvic floor musculaturemay react. The head and barrier may be so magnetized as to provide aconstant and reproducible attractive force between the head and thebarrier, a force which may be calibrated via magnet and materialselection. The head may be secured by thread engagement to a metalshaft. The shaft may have a measuring indication along a portion of alength of the shaft, may pass through the approximate center of thebarrier. The head may have a generally semi-spherical shaped upper endand a generally conical lower end. The barrier may have a generallyhourglass shaped barrier as to provide proper placement of the device inrelation to the patient's body. The lower end of the shaft may besecured by thread engagement to a handle to prevent the separation ofthe barrier from the shaft. The contraction of the pelvic floormusculature may move the head away from the stationary barrier, suchthat the shaft may slide upwards through the barrier. As the shaftslides through the barrier, an indicator opposite the barrier from thehead may slide down the shaft, indicating the degree to which the headhas traveled from its initial position when the pelvic floor musculaturewas at rest. This indication feature is a primary objective of thisinvention. The feature allows the physician and patient to measure thestrength of the pelvic floor musculature.

The magnetic head maybe detachable from the device shaft in such amanner that it may be reattached to a pin. The pin may provide an attachpoint for a lanyard to the magnetic head. Once the head is detached fromthe device and reattached to the lanyard, the patient may repeat theabove pelvic floor musculature contraction procedure using only the headand lanyard, as opposed to the entire device. In this manner, thepatient may continue to exercise the pelvic floor musculature in aprivate, self-paced manner, thereby increasing the strength of thepelvic floor musculature.

It is an object of this invention to provide a pelvic floor exercisingdevice comprising a shaft, a measuring indication along a portion of alength of the shaft, a head secured to an upper end of the shaft, abarrier moveably mounted on the shaft between the handle and the head,and an indicator moveably mounted on the shaft between a lower end ofthe shaft and the barrier that is moveably responsive to separation ofthe head from the barrier. It is a related object to provide such adevice that provides hygienic, safe, reproducible and private diagnosisand rehabilitation.

It is a feature of the present invention that the device may provide acombination of magnetically attractive head and barrier components on amutual shaft having a measuring indication. The barrier may have asubstantially hourglass shaped configuration. It is a further featurethat the barrier and the indicator may slide along a portion of thelength of the shaft. It is a further feature that the head may bedetached from the shaft and thereafter attached to a pin and lanyard.

It is an advantage of the present invention that the pelvic floorexercise device is relatively simple in design and construction, and ishighly reliable. It is an additional advantage that magnets offer anadvantage over the aforementioned utilization of weighted vaginal conesin strengthening the pelvic musculature, in that performing suchexercise is no longer postural based. Regardless of both body habitusand positioning, magnets may be calibrated so that exercises may beperformed in a reproducible and progressive manner. In this way,outcomes and process can be prospectively followed by the physician andpatient alike.

It is a further advantage of the present invention that magnetassociated therapies have an anti-microbial benefit shown in othervenues, and that such therapy may provide improvements not only infunction, but in the vaginal milieu as well. This advantageous featureis particularly of interest in the perimenopausal and postmenopausalpopulation in which both of these disorders are more prominent.

It is a further advantage that an alternative to medical and/or surgicaltherapies with respect to the dilemma of pelvic floor dysfunction isprovided by the apparatus, which may significantly improve upon analready existing non-surgical modality, and which has been proven anddesired.

These and further objects, features and advantages of the presentinvention will become apparent from the following detailed description,wherein references are made to the figures in the accompanying drawings.

The foregoing and the following disclosure and description of the pelvicfloor exercise device and methods are illustrative and explanatorythereof. This invention is not intended to be limited to the illustratedand discussed embodiments, as one skilled in the art will appreciatethat various changes in the size, shape and materials, as well as in thedetails of the construction or combination of features of the pelvicfloor exercise device may be made without departing from the spirit ofthe invention.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplified side view of a preferred embodiment of theinvention, illustrating a handle and detachable head connected by ashaft, with a barrier and indicator located adjacent one another on theshaft.

FIG. 2 is a simplified top view of the barrier shown in FIG. 1,illustrating the hourglass shape of the barrier.

FIG. 3 is a simplified side view of another embodiment of the invention,illustrating a detachable head assembled to a pin having an attachedlanyard.

FIG. 4 is a simplified side view of another embodiment of the invention,illustrating a handle and detachable head connected by a shaft, abarrier and indicator located adjacent one another on the shaft, andbiasing members between head and the barrier and between the barrier andthe handle.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference is made to the attached drawings only for the purpose ofdemonstrating preferred embodiments and not for the purpose of limitingthe same. FIG. 1 illustrates generally a pelvic floor exercise device inthe configuration used primarily for diagnosis. The device is held bythe handle 18 and placed into the injured tissue, such that the barrier14 rests against the exterior surface of the treatment area with thelong axis of the barrier 14 parallel to the patient's front-to-backdirection. FIG. 3 illustrates generally a second configuration usedprimarily for exercise treatment. In this configuration, the shaft 12 isremoved from the head 10 and replaced with the pin 20, to which alanyard 22 is secured. FIG. 4 illustrates generally another embodimentof the invention, in which biasing members 28 and 30 each oppose theseparation of the head from the barrier.

In the FIG. 1 embodiment, a handle 18 is secured to a lower end of ashaft 12. The handle 18 may be spatulated in a manner similar to areflex hammer. A head 10 is secured to an upper end of the shaft 12. Ina preferred embodiment, the head has a generally semi-spherical shapedupper end and a generally conical shaped or half-egg shaped lower end. Apreferred embodiment depicts a barrier 14 as moveably mounted on theshaft 12 between the head 10 and the handle 18. An indicator 16 ismounted on the shaft 12 between the barrier 14 and the handle 18, and ismoveably responsive to the separation of the head 10 from the barrier14. In a preferred embodiment, the head 10 and barrier 14 are composedof and/or house a magnetic material, providing a magnetically attractiveforce to one another, opposing the separation of the head from thebarrier. The magnetic material may have any desired configuration, andin the head 10 has a generally ball-shaped configuration, while in thebarrier 14 comprises a pair of elongate strips. The magnetic material 11and the strips 15 are shown in dashed lines in FIG. 1. Each of themagnetic materials may thus be embedded in a suitable plastic material.In a preferred embodiment, the barrier 14 has a generally hourglassshaped configuration to conform to the exterior genitalia of the user,and is relatively flat. The head and a portion of the shaft are thusinserted into the vagina to the extent permitted by the attraction ofthe barrier, with the relatively flat upper surface of the barrierresting against an exterior surface of the user surrounding her vagina.In a preferred embodiment, the shaft 12 has measuring indications 13along a portion of a length of the shaft. In the FIG. 3 embodiment, ahead 10 similarly has a generally semi-spherical shaped upper end and agenerally conical shaped lower end is secured to a lanyard 22.

In the FIG. 4 embodiment, a handle 18 is secured to a lower end of ashaft 12. A head 10 is secured to an upper end of the shaft 12. The headhas a generally semi-spherical shaped upper end and a generally conicalshaped lower end. The FIG. 4 embodiment depicts a barrier 14 as moveablymounted on the shaft 12 between the head 10 and the handle 18. Anindicator 16 is mounted on the shaft 12 between the barrier 14 and thehandle 18, and is moveably responsive to the separation of the head 10from the barrier 14. In the FIG. 4 embodiment, biasing members 28 and 30are moveably mounted on the shaft 12 between the head 10 and the barrier14 and between the barrier 14 and the handle 18. The barrier 14 has agenerally hourglass shaped configuration. In a preferred embodiment, theshaft 12 has a measuring indication along a portion of a length of theshaft.

In the preferred embodiments, the head 10 is approximately 3 centimetersin height and 2.5 centimeters in diameter. In the preferred embodiments,the barrier 14 is approximately 3 centimeters wide and 7 centimeterslong. In the preferred embodiments, the handle 18 is 7.5 centimeters inheight, and the handle 18 attached to the shaft 12 is approximately 14centimeters in height. The preferred embodiments depict the shaft 12 ashaving a substantially cylindrical cross-section, but the shaft 12cross-sectional shape may take the form of other geometric shapes. Thepreferred embodiment depict the barrier 14 and indicator 16 as eachhaving an internal aperture with a generally circular cross-section,such that the barrier 14 and indicator 16 may slide along the length ofthe shaft 12, but other embodiments may have cross-sectional shapes ofother geometric forms.

In a preferred embodiments, the handle 18 is attached to the shaft 12 bythreaded engagement, although other embodiments may utilize othermethods for attaching the handle 18 to the shaft 12, such as welding,adhesive, or by fabricating the handle 18 and shaft 12 as a singlecomponent. In the preferred embodiments, the head 10 is also attached tothe shaft 12 by thread engagement, although other embodiments mayutilize other forms of attachment. In the preferred embodiments, thehead 10 may be removeably attachable and re-attachable to the shaft 12,such that a pin 20 may be attached to the head 10 in the same mannerthat the shaft 12 is attached to the head 10. In the FIG. 3 embodiment,the pin 20 is mounted to the head 10 by the same means utilized to mountthe shaft 12 to the head 10, although other forms of attachment arepossible. A lanyard 22 composed of nylon twine is secured to the head10, although other embodiments may depict the lanyard 22 secured to thepin 20. Other embodiments may depict the lanyard 22 as composed of othermaterials.

The preferred embodiments depict the head 10 and the handle 18 securedto the shaft 12 by thread engagement, but other forms of engagement arepossible. A preferred embodiment depicts springs as biasing members 28and 30 between the head 10 and the barrier 14 and between the barrier 14and the handle 18, but other embodiments may include fewer or additionalsprings. When in use, the coil spring 30 is thus in tension, while thecoil spring 28 is in compression. Only one coil spring may be necessaryto achieve the desired results. Preferred embodiments depict a handle 18secured to the shaft 12, although other embodiment may replace thehandle 18 with a stop to prevent separation of the barrier 14 from theshaft 12, or may completely eliminate the handle 18, so as to allow theseparation of the barrier 14 from the shaft 12. In the preferredembodiments the shaft 12 is composed of metal, but other materials maybe used in other embodiments. In the preferred embodiments the head 10and the barrier 14 are composed of hard plastic, but other materials maybe used in other embodiments.

A process for diagnosing pelvic floor injury of injured musculaturecomprising providing a shaft 12, a portion of a length of the shaft 12having a measuring indication, mounting a removeably attachable andre-attachable head 10 on an upper end of the shaft 12, mounting amoveable barrier 14 on the shaft 12 between a lower end of the shaft 12and the head 10, and mounting a moveable indicator 16 on the shaft 12between a lower end of the shaft 12 and the barrier 14. The indicator 16is moveably responsive to separation of the head 10 from the barrier 14.In the FIG. 1 embodiment, magnetic materials 11 and 15 may act asbiasing members to oppose separation of the head from the barrier. Inthe FIG. 4 embodiment, biasing members 28 and 30 are provided each foropposing separation of the head 10 from the barrier 14. The head 10 isplaced into the injured musculature and thereafter the injuredmusculature is contracted, such that the pelvic floor musculature exertsan upward force against the head 10. Other embodiments may furthercomprise detaching the head 10 from the shaft 12 and re-attaching thehead 10 to a lanyard 22, thereafter proceeding with the pelvic floormusculature contraction described above. Other embodiments may furthercomprise examining the displacement of the indicator 16 along the shaft12 after the contraction of the pelvic floor musculature. Otherembodiments may further comprise providing a handle 18 secured to thelower end of the shaft 12.

The magnetic biasing members as disclosed herein are preferred. The coilspring biasing members, while functionally satisfactory, presentadditional contamination concerns. The spring biasing member could beprovided within rather than being external of the shaft 12.

Other biasing members may be used, such as pneumatic or hydrauliccylinders. Other embodiments are considered for this invention which mayconstruct any or all of the various components out of a variety ofmaterials, including resinous compounds, other non-metallic compounds,metallic compounds, special alloys, or any combination thereof.

While preferred embodiments of the present invention have beenillustrated in detail, it is apparent that modifications and adaptationsof the preferred embodiments will occur to those skilled in the art.However, it is to be expressly understood that such modifications andadaptations are within the spirit and scope of the present invention asset forth in the following claims.

What is claimed is:
 1. A pelvic floor exercise device, the devicecomprising: a shaft, a portion of a length of the shaft having ameasuring indication; a head secured to an upper end of the shaft; abarrier moveably mounted on the shaft between a handle and the head, thebarrier having a relatively flat upper surface for resting against anexterior surface of the user surrounding her vagina; and a biasingmember for opposing separation of the head from the barrier; anindicator moveably mounted on the shaft between a lower end of the shaftand the barrier and moveably responsive to separation of the head fromthe barrier during contraction of pelvic floor muscles.
 2. The device asdefined in claim 1, wherein the biasing member comprises: a magneticmaterial embedded within the head; and the barrier including metal forattraction to the magnetic material.
 3. The device as defined in claim1, wherein the biasing member comprises: a magnetic material embeddedwithin the barrier; and the head including metal for attraction to themagnetic material.
 4. The device as defined in claim 1, wherein thebiasing member comprises: a magnetic material embedded within the head;and another magnetic material embedded within the barrier.
 5. The deviceas defined in claim 1 wherein the biasing member is: a compressionspring extending between the head and the barrier.
 6. The device asdefined in claim 1, wherein the biasing member comprises: a tensionspring extending between the head and the barrier.
 7. The device asdefined in claim 1, wherein the barrier is generally hourglass shaped.8. The device as defined in claim 1, wherein the upper end of the headis generally semi-spherical in shape and the lower end of the head isgenerally conical in shape.
 9. The device as defined in claim 1, whereinthe head is removeably attachable and re-attachable.
 10. The device asdefined in claim 9, further comprising: a lanyard secured to the head.11. The device as defined in claim 1, wherein the shaft is composed ofmetal.
 12. A pelvic floor exercise device, the device comprising: ashaft, a portion of a length of the shaft having a measuring indication;a head secured to an upper end of the shaft; a barrier moveably mountedon the shaft between a handle and the head, the barrier having arelatively flat upper for resting against an exterior surface of a usersurrounding her vagina; and a biasing member for opposing separation ofthe head from the barrier, the measuring indication measuring separationof the head from the barrier during contraction of pelvic floor muscles.13. The device as defined in claim 12, further comprising: an indicatormoveably mounted on the shaft between a lower end of the shaft and thebarrier and moveably responsive to separation of the head from thebarrier.
 14. The device as defined in claim 12, wherein the upper end ofthe head is generally semi-spherical in shape and the lower end of thehead is generally conical in shape.
 15. A method of diagnosing pelvicfloor injury of injured musculature, comprising: providing a shaft, aportion of a length of the shaft having a measuring indication; mountinga removeably attachable and re-attachable head on an upper end of theshaft; mounting a moveable barrier on the shaft between a lower end ofthe shaft and the head; mounting a moveable indicator on the shaftbetween a lower end of the shaft and the barrier, the indicator beingmoveably responsive to separation of the head from the barrier;providing a biasing member for opposing separation of the head from thebarrier; placing the head into the injured musculature; and thereaftercontracting the injured musculature, such that the pelvic floormusculature exerts an upward force against the head to move theindicator on the shaft.
 16. The method as defined in claim 15, furthercomprising: thereafter examining the displacement of the indicator alongthe shaft.
 17. The method as defined in claim 15, further comprising:removing the head from the shaft; and securing a lanyard to the head.18. A pelvic floor exercise device, comprising: a shaft, portion of alength of a shaft having a measuring indication; a head secured to anupper end of the shaft; a barrier mounted on the shaft between a handleand the head, the barrier having a relatively flat upper surface forresting against an exterior surface of a user surrounding her vagina; anindicator moveably mounted on the shaft in response to separation of thehead from the barrier; a magnetic material in at least one of the headand the barrier; and at least one of a metal material and anothermagnetic material within the other of the head and the barrier.
 19. Thedevice as defined in claim 18, wherein the magnetic material is withinthe head, the barrier includes metal for attraction to the magneticmaterial.
 20. The device as defined in claim 18, wherein the magneticmaterial is embedded in the barrier, and the head includes metal forattraction to the magnetic material.
 21. The device as defined in claim18, wherein the barrier is generally hourglass shaped.
 22. The device asdefined in claim 18, wherein the head is removably attachable andre-attachable to the upper end of the shaft.